Otsuka Pharmaceutical Development and Commercialisation, Inc. and Otsuka Pharmaceutical have announced that the US Food and Drug Administration (FDA) has granted approval of SIMTRIYO (centanafadine), a once-daily extended-release capsule for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg.

As the first and only approved Norepinephrine, Dopamine, Serotonin Reuptake Inhibitor (NDSRI), SIMTRIYO introduces a new treatment approach for patients and healthcare professionals managing this complex and highly individualised condition. By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, SIMTRIYO increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation.

SIMTRIYO, an NDSRI and Central Nervous System (CNS) stimulant, is expected to be available later this year following scheduling by the US Drug Enforcement Administration (DEA).

The approval is supported by results from four pivotal phase 3 clinical trials evaluating the efficacy and safety of SIMTRIYO across adult, adolescent, and pediatric patients. In these phase 3 clinical studies, SIMTRIYO demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in children and adolescents and the adult ADHD Investigator Symptom Rating Scale (AISRS) in adults. In pediatric and adult studies, improvements in ADHD symptoms were seen as early as week 1. The most common adverse events include decreased appetite, nausea, rash, headache, and abdominal pain in children and adolescents, and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.

John Kraus, MD, PhD, Executive Vice President (EVP) and Chief Medical Officer (CMO), Otsuka, said, “The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition. ADHD is a complex and highly individualised disorder that can affect people throughout childhood, adolescence, and adulthood. Today’s approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families managing ADHD. We are deeply grateful to the patients, caregivers, investigators, and clinical teams whose participation made this achievement possible.”

Additional clinical research continues to expand the evidence base for centanafadine. In a recently completed phase 3b study in adults with ADHD and comorbid anxiety, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo, providing additional insight into its clinical profile.

ADHD is a chronic neurodevelopmental disorder characterised primarily by impairments in attention, hyperactivity, and impulsivity. The disorder can affect academic performance, occupational functioning, social relationships, and challenges that impact patients’ daily lives. Although ADHD is often diagnosed during childhood, symptoms frequently persist into adolescence and adulthood.

Dr. Lenard A. Adler, Director of the adult ADHD Program, NYU Langone Health, said, “ADHD can significantly affect many aspects of daily life across school, work, and relationships. Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning. The approval of SIMTRIYO introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients. Having more therapeutic choices is important because ADHD is a highly individualised condition and treatment decisions should reflect the unique needs of each patient.”